[e-drug] WHO DG finally approves 14th WHO Essential Model List

["E-Drug" <e-drug@healthnet.org>]

E-DRUG: WHO DG finally approves 14th WHO Essential Model List
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[E-drug reported earlier that the DG of WHO had stalled the publication of the 14th Model Essential Medicines List, probably as it contained 2 drugs that may be used in (inter alia) safe abortion. The USA had reportedly objected to the list. With the WHO Assembly passed and the budget approved, the DG probably saw it safe to publish the list with a minor comment. The EML committee had threatened to pull out if the list would be altered; this risk is now averted, and we can all go and adapt our national lists again...

I am breaking the news with Andy Gray's message to Druginfo, as Andy was one of the members of the committee.

Please note that the links in his message appear not (any more) to work; the 14th EML list can now be downloaded from
http://www.who.int/medicines/organization/par/edl/eml.shtml in both Word and PDF. Crossposted from Druginfo with thanks. WB]


Hi all

After a long delay, caused by concern about the decision by the WHO Expert Committee on the Selection and Use of Essential Medicines (which met on 7-11 March 2005) to list the combnination of mefipristone and misoprostol, the WHO D-G has finally approved the List and Report.

The full List can be accessed at:
http://www.who.int/medicines/library/general/1-EML14Final_010705.pdf

The unedited report of the Committee is at:http://www.who.int/medicines/library/general/1-ReportFinal-unedited_010705.pdf

The D-G has inserted the following text in the List and Report, linked to the mefipristone and misoprostol section: ""Where permitted under national law and where culturally acceptable".

The relevant section from the report therefore reads as follows (with the references cited listed below):

22.1. Mifepristone with misoprostol

An application was received from the UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), the Department of Reproductive Health and Research, WHO and the Geneva Foundation for Medical Education and Research to include sequential administration of oral mifepristone and intravaginal misoprostol for induction of medical abortion.

The Committee noted a Cochrane review of 39 trials (ref 45) which showed that sequential administration of oral single dose mifepristone oral 200 mg tablet followed by vaginal single dose misoprostol 800 micrograms in 36 to 48 hours is effective, safe and convenient in inducing medical abortion of up to 9-weeks of pregnancy. Major complications seem to be rare, the most common complication being blood transfusion (about 0.2%). It was reported that the side-effects were mainly due to prostaglandins (nausea, vomiting, and diarrhoea). Higher doses were associated with increased side-effects such as nausea and vomiting. In comparison to surgical abortion, (ref 46) the risks of bleeding, abdominal pain, fever and dizziness in the medical abortion population were higher than those in the surgical abortion population. In addition, the duration of bleeding caused by medical abortion was longer than that caused by surgical abortion.

The Committee noted from the application that the mifepristone/misoprostol regimen for
medical abortion in the first nine weeks of pregnancy has been registered in the following
countries in Europe: Austria, Belgium, Finland, France, Germany, Greece, Luxembourg, the Netherlands, Norway, Romania, Spain, Sweden, Switzerland and the UK. The regimen has also been registered in Azerbaijan, Georgia, India, Israel, New Zealand, the People's Republic of China, the Russian Federation, South Africa, Tunisia, Ukraine, the USA, Uzbekistan and Viet Nam.

The Committee noted that the use of this medication in medical abortion should be undertaken under close medical supervision, and that its efficacy decreases after nine weeks of gestation. The Committee therefore recommended that mifepristone (200 mg tablet) followed by misoprostol (200 micrograms tablet) be included on the complementary list of the Model List for medical abortion within nine weeks of pregnancy, and that the following footnote be added: "Requires close medical supervision".

Note by the Secretariat: In reviewing the recommendation relating to this combination of
products, the Director-General decided to add a note adjacent to the combination in the WHO Model List stating "Where permitted under national law and where culturally acceptable".

45 Kulier R, G|lmezoglu AM, Hofmeyr GJ, Cheng LN, Campana A. Medical methods for first trimester abortion. The Cochrane Database of Systematic Reviews 2004, Issue 2 (http://www.cochrane.org/cochrane/revabstr/AB002855.htm, date
accessed 31 Jan 2005)
46 Zou Y, Li YP, Lei ZW, Lu L, Jiang S, Li Q. Side effect of mifepristone in combination with misoprostol for medical abortion. Zhonghua Fu Chan Ke Za Zhi 2004; 39: 39-42.

regards
Andy


~~~~~~~~~~~~~~~~~~~
Andy Gray MSc(Pharm) FPS
* Senior Lecturer
Dept of Therapeutics and Medicines Management
* Study Pharmacist
Centre for the AIDS Programme of Research 
in South Africa (CAPRISA)
Nelson R Mandela School of Medicine
University of KwaZulu-Natal
PBag 7 Congella 4013
South Africa
Tel: +27-31-2604334/4298 Fax: +27-31-2604338
email: graya1@ukzn.ac.za or andy@gray.za.net
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